Second Africa TB Regional Conference on Management of TB Medicines

Africa TB Conference 2012, Zanzibar December 5-7, 2012

Minimal TB Medicine wastage: Nigeria Experience switching TB

regimens

Presentation by

Dr Joshua Obasanya – NTP Manager Pharm Linus Odoemene – Head of Logistics unit

Background Regimen Switch • New TB treatment guidelines released by WHO/Global Drug Facility (GDF), in 2010

strongly recommended the phasing out of the ethambutol (E)/isoniazid (H) containing category one regimen.

The New Regimen • Contains rifampicin (R) and isoniazid (H) in continuation phase. Resistance to RH

technically defines multidrug-resistantn (MDR) TB

Nigeria must switch in 2011 or face widespread stock-outs because the GDF, sole supplier for Nigeria, had de-listed EH from product list

NTP Challenges About 30 out of 37 state TB programs are considered too weak to commence RH regimen. This raises grave concerns about stock-outs, high wastages, and RH resistance.

CAUTION: Resistance to RH is MDR-TB

Objective of the Presentation

• To describe how the NTP has successfully switched from EH to RH category one regimen with minimal stock-outs and wastages

PSM Flow Chart

Service delivery points (SDPs)

State medical stores

FCMS

Partners Donors

GDF/GLC

NTP PSM

FMOH coordinating bodies •Principal recipients •CCM •PSM TWG

Carrier

Zonal stores

National level

Zonal (region) level

State level

Local govt. area level

SDP level

Anticipated Risks for National Level Regimen Switch STOCK OUTS: Unreliable procurement and shipment system • Shipments delayed for 6-13 months • Shipments over fragmented (4-6 batches instead of 2) • EH had been phased out of the GDF list of drugs • Weak logistics management information system (LMIS) in country HIGH DRUG WASTAGE • Excess loose drug components: e.g., excess EH of 290,000 blisters ($380,000) • Low capacity to manage patients kits (NTP was also transiting from use of loose

drugs to patient kits) • Low capacity to manage drugs at SDP level LOW CAPACITY AT THE SDP LEVEL • Weak drug/programmatic management of TB in many states • High defaulter rates in many states

The Transition Process

Objectives • To strengthen the capacity of the central unit of NTP

to plan and coordinate the transition process. • To improve the standards of DOTS implementation in

line with the criteria for switching to RH regimen.

Criteria for Selecting States for Switching

STATE LEVEL • Programmatic capacity of states to implement RH regimen

– 10 patient index values: 9 – 12 – SDP Reporting > 90% – CAT 1 availability at SDP > 90% at quarter end – Capacity to use LMIS for performance improvement – Defaulter rate: not more than 5 -7% – Treatment success rate: greater than 80%

NATIONAL LEVEL • Favorable RH/EH regimen coverage (months of stock) • Availability of category 2 regimen (in view of low stock level of category 2 ) • Considerations for final mop-up in each zone (region)

Approach • National committees for transition planning and

monitoring • GAP analysis • Sensitizing and training of mangers, supervisors, and

DOTS providers • Development and use of EH/RH status monitoring tool –

(switch surveyor—designed and developed by NTP) • Loose drug bundling (conversion to patient kits) • Procurement of loose drugs Any state program, once transitioned to RH regimen, cannot be returned to the EH regimen.

Approach and Activities

• National committees for transition planning and monitoring – Transition plan developed (World Health Organization

(WHO) support) – Setting of standards of program performance for states

(WHO support). Development and printing of two SOPs (TBCARE support):

• SOP on the use of 6 months regimen • SOP for the engagement of treatment supporter

• GAP analysis (TBCARE support) • General sensitization using quarterly review meetings

(GF sctivity) • “SWITCH SURVEYOR” tool developed (NTP )

Approach and Activities (2)

• Nationwide stock assessment(NTP) • Order placed for RHZE to mop up excess EH (GF

support) • Mentoring and supportive supervision to selected

states (TBCARE support) • Post implementation evaluation/On-site data

validation • Any state programme, once transited to RH regimen

cannot be returned to the old EH regimen.

Phase – In Approach (1)

Phase – In Approach(2)

Time to focus on a few States: • Assess performance of States • Sensitize identified States (to be switched) • Raise capacity of weak States enough to implement 6

months regimen • Determine EH/RH coverage before next shipment • Save EH • Boost overall supply of CAT 1 kits

Timelines • Drug order (6 months regimen) placed - Jan 2011 • Determination of status of excess loose drug components – Jan 2011 • Development of “switch surveyor” – (RH/EH monitoring tool ) – Mar 2011 • Selection of the first 13 states to switch – March 2011 • SOP on 6 months regimen disseminated – April 2011 • Sensitisation of state control managers and supervisors – April–Sept 2011 • Mentoring, monitoring, and supportive supervision – May–Sept 2011 • First batch implementation: 15 states (58% case burden) – Oct.2011 • Delivery of new RHZE orders – Feb 2012 • Second batch implementation: 3 states (08% case burden) - April 2012 • Third batch implementation: 3 states (06% case burden) - July 2012 • Fourth batch implementation: 5 states (09% case burden) - July 2012 • So far: 21 states (81%) of national case burden • 9 states expected to transition in Jan 2013 • Balance of 2 states in April 2013

Screenshot of SWITCH SURVEYOR” tool CASE BURDEN

Benue 6 STATE POSITION

FCT 6 Lagos 1

Kogi 6 Kano 2

Kwara 6 Benue 3

Nasarawa 6 Oyo 4

Niger 8 Kaduna 5

Plateau 6 Plateau 6Borno 7

Adamawa 6 Delta 8

Bauchi 6 AKWAIBOM 9Borno 8 Adamawa 10

Gombe 6 Nasarawa 11Taraba 6 Bauchi 12

Nex

t sw

itche

s

Select state to switch Ranking

To activate SWITCH, replace “8 “with “6”

“SWITCH SURVEYOR” Tool – View RH/EH Projection

00-Jan-00 0 00-Jan-00 0 00-Jan-00 0

00-Jan-00 0 00-Jan-00 0 00-Jan-00 0

REGIMEN 6-MONTHS Regular COMBINED 00-Jan-00 0 00-Jan-00 0 00-Jan-00 0AMC 9,611.6 2,192.6 11,804.2 04-Jun-13 0 00-Jan-00 0 00-Jan-00 0MOS 8.1 5.1 7.5 01-Jun-13 899 00-Jan-00 0 18-May-13 0

Stock out date 04-Jun-13 05-Mar-13 18-May-13 02-May-13 10,511 00-Jan-00 0 02-May-13 6,30701-Apr-13 20,123 05-Mar-13 0 01-Apr-13 18,11102-Mar-13 29,734 02-Mar-13 181 02-Mar-13 29,91531-Jan-13 39,346 31-Jan-13 2,374 31-Jan-13 41,71931-Dec-12 48,957 31-Dec-12 4,566 31-Dec-12 53,524

6-MONTHS Regular ALL 01-Dec-12 58,569 01-Dec-12 6,759 01-Dec-12 65,328States in category

26 11 37 31-Oct-12 68,180 31-Oct-12 8,951 31-Oct-12 77,132% in category 70.3% 29.7% 100% Oct-12 77,792 Oct-12 11,144 Oct-12 88,936Case finding 115,339 26,311 141,650 Coverage Balance Coverage Balance Coverage Balance

% in category 81.4% 18.6% 100% 6-MONTHS 8-MONTHS COMBINEDCAT 1 KITS

State/case data

PIPELINE ANALYSIS

Implementation So Far

0

58

66 72

81

100 100

42

34 28

19

0 0

20

40

60

80

100

120

July 2011 Oct 2011 April 2012 Jul 2012 Oct 2012 Jan 2013 April 2013 Jul 2013

% cases RH regimen

% cases EH regimen

Outcomes

• Successful transition of 81% of the nations Adult CAT 1 caseload to RH regimen while enhancing CAT 1 stock

• NTP saved more than 401,827 blisters of EH valued at $425,631.49,

• Over all savings from improved management of drugs and supplies exceeded a year’s budget for drug procurement

Strengths

• Support from partners, notably WHO and TBCARE • Strong teams in 17 states (about 47%)

– achieved through recommendation of NTP to states to delegate duties to Logistics, M&E Lab officers

• Capacity in NTP to develop LMIS Tools, examples: – (a) Switch surveyor - employed in this project to monitor how long

stocks of RH and EH would last. – (b) PICKnPACK - LMIS tool that provides the “third eye” managers need

to “see” where issues come from; measure current performance of the supply system; provide feedback to influence behaviour change; and provide support for some “difficult to do tasks”.

Challenges BEFORE TRANSITION: • Unreliable procurement and shipment system (from slide 6)

– Delayed shipment (6-13 months) – Fragmented shipments (4-6 batches instead of 2) – EH phased out by GDF product list

• Drug management capacity – Large quantities of loose drugs at risk of expiring (EH – 290,000

blistered valued at $380,000) – Program had little experience for managing patient kits

DURING IMPLEMENTATION: • Weak teams in 20 states – mostly States failing to implement NTP

recommendation on delegation of duties • Unreliable procurement & shipment procedure • Return of un-usable commodities

Lessons

• Early preparation is key to success • Decide which approach, nationwide or phased in? • Stock management of EH at all levels • Carefully set your targets and stick to it • Accurate stock projection, forecasting and pipeline

monitoring